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Medivir Announces Phase III Data for Simeprevir Demonstrating Efficacy and Safety in Genotype 1 Hepatitis C Patients



  Medivir Announces Phase III Data for Simeprevir Demonstrating Efficacy and
  Safety in Genotype 1 Hepatitis C Patients

Business Wire

STOCKHOLM -- December 20, 2012

Regulatory News:

  * Simeprevir achieved SVR12 rates (viral cure) of 79% to 81% in the three
    pivotal phase III trials QUEST-1, QUEST-2 and PROMISE in genotype 1
    hepatitis C patients.
  * The overall results demonstrate that simeprevir is safe and well tolerated
    with a safety profile of the simeprevir treatment arms similar to the
    placebo control.
  * A majority of the patients, 85-93%, were able to stop all treatment after
    24 weeks.

Medivir AB (OMX: MVIR) today announced top-line results from three pivotal
phase III trials examining the one pill, once-daily, investigational protease
inhibitor, simeprevir (TMC435), administered with pegylated interferon and
ribavirin.

Results from the QUEST-1 and QUEST-2 trials found that 80% and 81% of
treatment-naive patients with chronic genotype 1 hepatitis C infection who
were treated with simeprevir achieved sustained virologic response 12 weeks
after the planned end of treatment (SVR12). Results from the PROMISE trial
found that 79% of prior relapsed patients treated with simeprevir achieved
SVR12. All three studies utilized response-guided treatment (RGT) criteria and
85%, 91% and 93 % of the patients, respectively, were eligible to stop all
treatments after 24 weeks.

The overall safety, tolerability and efficacy results from these studies were
consistent with those previously obtained in phase II studies.

Final analysis of the phase III trials is ongoing and the full data set from
these studies will be submitted for presentation at future scientific
conferences.

"We are extremely happy about the data from these phase III studies, which
robustly demonstrate high cure rates in both treatment-experienced, so called
relapsers, and treatment-naïve patient groups, both including patients with
severe liver disease. Together with the very good safety profile and the fact
that a large proportion of the patients were eligible to end all treatments in
a shorter time frame as compared to current standard of care, should provide
new hope for large patient groups with this disease”, said Charlotte Edenius,
EVP of Research and Development, Medivir AB. “We look forward to seeking
regulatory approvals to bring simeprevir forward to help treat people living
with chronic hepatitis C."

QUEST-1 (C208), QUEST-2 (C216) and PROMISE (C3007)

In the global QUEST-1 and QUEST-2 trials, 394 and 391 respectively,
treatment-naïve patients with genotype 1 hepatitis C were randomized to
receive either 150 mg of once-daily simeprevir for 12 weeks plus pegylated
interferon and ribavirin for 24 or 48 weeks based upon response guided
treatment criteria (simeprevir group) or pegylated interferon and ribavirin
alone for 48 weeks (control group).

In the PROMISE study, 393 patients, who had previous relapse after completing
HCV treatment with pegylated interferon and ribavirin, were randomized to
receive either 150 mg of once-daily simeprevir for 12 weeks plus pegylated
interferon and ribavirin for 24 or 48 weeks based on response guided treatment
criteria (simeprevir group) or pegylated interferon and ribavirin alone for 48
weeks (control group).

Summary Table

Sustained Virologic Response (SVR12 Rates in Simeprevir (TMC435) Dose Groups
(150 mg q.d.) vs PR PlaceboIntention-To-Treat (ITT) Population
                                                                Treatment
                              Treatment Naive Patients          Experienced -
                                                                Prior Relapser
                                                                Patients
                              QUEST-1          QUEST-2
                              TMC435 150       TMC435 150       PROMISE TMC435
% (N)                         mg QD            mg QD            150 mg QD
                              12wks            12wks            12wks PR24/48
                              PR24/48          PR24/48          wks
                              wks              wks
SVR12                         80 (264)         81 (257)         79 (260)
SVR12 Placebo PR48wks         50 (130)         50 (134)         37 (133)
Percentage of Patients in Simeprevir Treatment Arms Meeting RGT Criteria Who
Could Stop All Treatment at Week 24
                QUEST-1                        QUEST-2          PROMISE
%               85                             91               93
Percentage of Patients Who Displayed Advanced Liver Disease Upon Study Entry
METAVIR Score F3-F4 (%)       30               22               31

q.d.: once daily; PR: pegIFNalpha and ribavirin;
SVR12: patients with undetectable HCV RNA (<25 IU/mL Undetectable) 12 weeks
after planned EoT.
All simeprevir (TMC435) groups: p<0.001 vs placebo.
Prior Relapser: undetectable HCV RNA at EoT and detectable within 12/24 weeks
of follow-up
RGT: Response Guided Treatment: HCV RNA < 25 IU/mL (detectable or
undetectable) at Week 4 and undetectable
HCV RNA (< 25 IU/mL undetectable) at Week 12 (all other patients continued
Peg-IFN/RBV up to W48)
 

Summary – Safety and Tolerability

Simeprevir was generally safe and well tolerated and overall incidence of
adverse events (AEs), including rash and anemia was similar to the placebo
control and consistent with prior simeprevir phase II studies.

In all three phase III studies, AEs leading to permanent discontinuation were
lower in the simeprevir treated subjects compared to the placebo control
(pegylated interferon and ribavirin).

Mild and reversible increases in bilirubin (total, direct and indirect) were
observed in simeprevir dose groups. There were no meaningful differences
between treatment groups for any of the other laboratory parameters. There
were no clinically significant findings on vital signs. Mean alanine
aminotransferase (ALT) levels decreased in all simeprevir treatment groups.

Conference call Today, 20 December, at 14.00 (CET)

Phone numbers for participants from:

Sweden 0200 89 63 77

Europe +44 (0)20 3003 2666

USA +1 866 966 5335

The conference call will also be streamed live via a link on the website:
www.medivir.com

About Simeprevir (TMC435)

Simeprevir, a potent investigational NS3/4A protease inhibitor jointly
developed by Janssen and Medivir, is currently in phase III studies as a one
pill once-daily treatment taken in combination with pegylated interferon and
ribavirin for the treatment of genotypes 1 and 4 chronic hepatitis C
infection.

Global phase III studies of simeprevir include QUEST-1 and QUEST-2 in
treatment-naïve patients, PROMISE in patients who have relapsed after prior
interferon-based treatment, ATTAIN in prior null-responder patients and
studies in Japanese HCV genotype 1 patients. In parallel to these trials,
phase III studies for simeprevir are ongoing in treatment-naïve and
treatment-experienced HIV-HCV co-infected patients and in HCV genotype 4
patients.

Simeprevir is also being studied in phase II interferon-free trials both with
and without ribavirin:

  * Simeprevir in combination with Gilead Sciences’ sofosbuvir (GS7977) in
    hepatitis C genotype 1 treatment-naïve or prior null responder patients.
  * Simeprevir in combination with BMS’s, daclatasvir in hepatitis C genotype
    1 treatment-naïve or prior null responder patients
  * Simeprevir in combination with Janssen’s TMC647055 and low dose ritonavir
    in hepatitis C genotype 1 treatment-naïve, prior relapser or null
    responder patients
  * Simeprevir in combination with Vertex’s VX-135 in hepatitis C genotype 1
    treatment-naïve patients to commence in 2013

For additional information about simeprevir, please visit
www.clinicaltrials.gov

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading
cause of chronic liver disease and liver transplants. The World Health
Organization estimates that nearly 170 million people worldwide, approximately
3% of the world's population, are infected with hepatitis C virus (HCV). The
CDC (Centers for Disease Control and Prevention) has reported that more than
three million people in the United States are chronically infected with HCV.

About Medivir

Medivir is an emerging research-based pharmaceutical company focused on
infectious diseases.

Medivir has world class expertise in polymerase and protease drug targets and
drug development which has resulted in a strong infectious disease R&D
portfolio. The Company’s key pipeline asset is simeprevir (TMC435), a novel
protease inhibitor in phase III clinical development for hepatitis C that is
being developed in collaboration with Janssen R&D Ireland.

In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia
and today Medivir has a broad product portfolio with prescription
pharmaceuticals in the Nordics.

For more information about Medivir, please visit the Company’s website:
www.medivir.com

This information was brought to you by Cision http://www.cisionwire.com

Contact:

Medivir
Rein Piir, EVP Corporate Affairs & IR
Direct: +46 8 440 6550
Mobile: +46 708 537 292
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